Commission Regulation (EC) No 1443/2006 of 29 September 2006 concerning the permanent authorisations of certain additives in feedingstuffs and an authorisation for 10 years for a coccidiostat (Text with EEA relevance)
Modified by
  • Commission Regulation (EC) No 887/2009of 25 September 2009concerning the authorisation of a stabilised form of 25-hydroxycholecalciferol as a feed additive for chickens for fattening, turkeys for fattening, other poultry and pigs(Text with EEA relevance), 32009R0887, September 26, 2009
  • Commission Implementing Regulation (EU) 2017/1145of 8 June 2017on the withdrawal from the market of certain feed additives authorised pursuant to Council Directives 70/524/EEC and 82/471/EEC and repealing the obsolete provisions authorising those feed additives(Text with EEA relevance)Commission Implementing Regulation (EU) 2018/353of 9 March 2018correcting Implementing Regulation (EU) 2017/1145 on the withdrawal from the market of certain feed additives authorised pursuant to Council Directives 70/524/EEC and 82/471/EEC and repealing the obsolete provisions authorising those feed additives(Text with EEA relevance), 32017R114532018R0353, June 29, 2017
  • Commission Implementing Regulation (EU) 2018/353of 9 March 2018correcting Implementing Regulation (EU) 2017/1145 on the withdrawal from the market of certain feed additives authorised pursuant to Council Directives 70/524/EEC and 82/471/EEC and repealing the obsolete provisions authorising those feed additives(Text with EEA relevance), 32018R0353, March 12, 2018
Commission Regulation (EC) No 1443/2006of 29 September 2006concerning the permanent authorisations of certain additives in feedingstuffs and an authorisation for 10 years for a coccidiostat(Text with EEA relevance)
Article 1The preparations belonging to the group "Enzymes", as specified in Annex I, are authorised without a time limit as additives in animal nutrition under the conditions laid down in that Annex.
Article 2The preparation belonging to the group "Coccidiostat and other medicinal substances", as specified in Annex II, is authorised for 10 years as additive in animal nutrition under the conditions laid down in that Annex.
Article 3The preparation belonging to the group "Vitamins, provitamins and chemically well-defined substances having similar effect", as specified in Annex III, is authorised without a time limit as additive in animal nutrition under the conditions laid down in that Annex.
Article 4This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.ANNEX I
1 U is the amount of enzyme which liberates 1micromole of inorganic phosphate from phytate per minute at pH 5,5 and 37 °C.1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from oat spelt xylan per minute at pH 5,3 and 50 °C.Enzymes
EC NoAdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
Units of activity/kg of complete feedingstuff
E 16393-phytaseEC 3.1.3.8Preparation of 3-phytase produced by Hansenula polymorpha (DSM 15087) having a minimum activity of:Coated form: 2500 U/gLiquid forms: 5000 U/gChickens for fattening—250 U—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.Recommended dose per kg of complete feedingstuff: 250-1000 U/kg3.For use in compound feed rich in phytin-bound phosphorus such as maize, soya, wheat, barley, rye.Without a time limit
Turkeys for fattening—250 U—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.Recommended dose per kg of complete feedingstuff: 250-1000 U/kg3.For use in compound feed rich in phytin-bound phosphorus such as maize, soya, wheat, barley, rye.Without a time limit
Laying hens—250 U—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.Recommended dose per kg of complete feedingstuff: 250-1000 U/kg3.For use in compound feed rich in phytin-bound phosphorus such as maize, soya, wheat, barley, rye.Without a time limit
PigletsFour months500 U—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.Recommended dose per kg of complete feedingstuff: 500-1000 U/kg3.For use in compound feed rich in phytinbound phosphorus such as maize, soya, wheat, barley, rye.Without a time limit
Pigs for fattening—250 U—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.Recommended dose per kg of complete feedingstuff: 250-1000 U/kg3.For use in compound feed rich in phytinbound phosphorus such as maize, soya, wheat, barley, rye.Without a time limit
Sows—500 U—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.Recommended dose per kg of complete feedingstuff: 500-1000 U/kg3.For use in compound feed rich in phytinbound phosphorus such as maize, soya, wheat, barley, rye.Without a time limit
E 1628Endo-1,4-beta-xylanaseEC 3.2.1.8Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 2105) having a minimum activity of:Powder form:Endo-1,4-beta-xylanase: 8000 U/gLiquid form:Endo-1,4-beta-xylanase: 8000 U/mlPiglets (weaned)—Endo-1,4-beta-xylanase: 4000 U—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.Recommended dose per kg of complete feedingstuff:Endo-1,4-beta-xylanase: 4000 U.3.For use in compound feed rich in nonstarch polysaccharides (mainly arabinoxylans), e.g. containing more than 35 % wheat.4.For use in weaned piglets until approximately 35 kg.Without a time limit
ANNEX II
Coccidiostats and other medicinal substances
Registration number of additiveName and registration number of person responsible for putting additive into circulationAdditive(Trade name)Composition, chemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
mg of active substance/kg of complete feedingstuff
E 773Phibro Animal Health, s.a.Semduramicin sodium(Aviax 5 %)Additive composition:Semduramicin sodium: 51,3 g/kgSodium carbonate: 40 g/kgMineral oil: 30-50 g/kgSodium aluminosilicate: 20 g/kgSoybean mill run: 838,7-858,7 g/kgActive substance:SemduramicinC45H76O16CAS number: 113378-31-7Semduramicin sodiumC45H75O16NaCAS number: 119068-77-8sodium salt of a monocarboxylic acid polyether ionophore produced by Actinomadura roseorufa (ATCC 53664)Related impurities:Descarboxylsemduramicin, ≤ 2 %Desmethoxylsemduramicin, ≤ 2 %Hydroxysemduramicin, ≤ 2 %Total: ≤ 5 %Chickens for fattening—2025Use prohibited at least five days before slaughter.Simultaneous use of semduramicin and tiamulin may induce a temporary reduction of feed consumption and water intake.10 years from the date to entry into force of Regulation
ANNEX III
40 IU cholecalciferol (vitamin D3) = 0,001 mg cholecalciferol (vitamin D3).Vitamins, provitamins and chemically well defined substances having similar effect
EC NoAdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMaximum content mg/kg of complete feedingstuffOther provisionsEnd of period of authorisation
2. Vitamin D
E 670 a25-hydroxycholecalciferol25-hydroxycholecalciferol(minimum 94 % purity)Chickens for fattening—0,100 mgThe mixture of 25-hydroxylcholecalciferol with vitamin D3 (cholecalciferol) is allowed, provided that the total amount of the mixture does not exceed 0,125 mg/kg complete feedingstuffWithout a time limit
Laying hens—0,080 mgThe mixture of 25-hydroxylcholecalciferol with vitamin D3 (cholecalciferol) is allowed, provided that the total amount of the mixture does not exceed 0,080 mg/kg complete feedingstuffWithout a time limit
Turkeys—0,100 mgThe mixture of 25-hydroxylcholecalciferol with vitamin D3 (cholecalciferol) is allowed, provided that the total amount of the mixture does not exceed 0,125 mg/kg complete feedingstuff.Without a time limit
Article 1The preparations belonging to the group "Enzymes", as specified in Annex I, are authorised without a time limit as additives in animal nutrition under the conditions laid down in that Annex.
Article 2The preparation belonging to the group "Coccidiostat and other medicinal substances", as specified in Annex II, is authorised for 10 years as additive in animal nutrition under the conditions laid down in that Annex.
Article 3The preparation belonging to the group "Vitamins, provitamins and chemically well-defined substances having similar effect", as specified in Annex III, is authorised without a time limit as additive in animal nutrition under the conditions laid down in that Annex.
Article 4This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.ANNEX I
1 U is the amount of enzyme which liberates 1micromole of inorganic phosphate from phytate per minute at pH 5,5 and 37 °C.1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from oat spelt xylan per minute at pH 5,3 and 50 °C.Enzymes
EC NoAdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
Units of activity/kg of complete feedingstuff
E 16393-phytaseEC 3.1.3.8Preparation of 3-phytase produced by Hansenula polymorpha (DSM 15087) having a minimum activity of:Coated form: 2500 U/gLiquid forms: 5000 U/gChickens for fattening—250 U—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.Recommended dose per kg of complete feedingstuff: 250-1000 U/kg3.For use in compound feed rich in phytin-bound phosphorus such as maize, soya, wheat, barley, rye.Without a time limit
Turkeys for fattening—250 U—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.Recommended dose per kg of complete feedingstuff: 250-1000 U/kg3.For use in compound feed rich in phytin-bound phosphorus such as maize, soya, wheat, barley, rye.Without a time limit
Laying hens—250 U—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.Recommended dose per kg of complete feedingstuff: 250-1000 U/kg3.For use in compound feed rich in phytin-bound phosphorus such as maize, soya, wheat, barley, rye.Without a time limit
PigletsFour months500 U—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.Recommended dose per kg of complete feedingstuff: 500-1000 U/kg3.For use in compound feed rich in phytinbound phosphorus such as maize, soya, wheat, barley, rye.Without a time limit
Pigs for fattening—250 U—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.Recommended dose per kg of complete feedingstuff: 250-1000 U/kg3.For use in compound feed rich in phytinbound phosphorus such as maize, soya, wheat, barley, rye.Without a time limit
Sows—500 U—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.Recommended dose per kg of complete feedingstuff: 500-1000 U/kg3.For use in compound feed rich in phytinbound phosphorus such as maize, soya, wheat, barley, rye.Without a time limit
E 1628Endo-1,4-beta-xylanaseEC 3.2.1.8Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 2105) having a minimum activity of:Powder form:Endo-1,4-beta-xylanase: 8000 U/gLiquid form:Endo-1,4-beta-xylanase: 8000 U/mlPiglets (weaned)—Endo-1,4-beta-xylanase: 4000 U—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.Recommended dose per kg of complete feedingstuff:Endo-1,4-beta-xylanase: 4000 U.3.For use in compound feed rich in nonstarch polysaccharides (mainly arabinoxylans), e.g. containing more than 35 % wheat.4.For use in weaned piglets until approximately 35 kg.Without a time limit
ANNEX II
Coccidiostats and other medicinal substances
Registration number of additiveName and registration number of person responsible for putting additive into circulationAdditive(Trade name)Composition, chemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
mg of active substance/kg of complete feedingstuff
E 773Phibro Animal Health, s.a.Semduramicin sodium(Aviax 5 %)Additive composition:Semduramicin sodium: 51,3 g/kgSodium carbonate: 40 g/kgMineral oil: 30-50 g/kgSodium aluminosilicate: 20 g/kgSoybean mill run: 838,7-858,7 g/kgActive substance:SemduramicinC45H76O16CAS number: 113378-31-7Semduramicin sodiumC45H75O16NaCAS number: 119068-77-8sodium salt of a monocarboxylic acid polyether ionophore produced by Actinomadura roseorufa (ATCC 53664)Related impurities:Descarboxylsemduramicin, ≤ 2 %Desmethoxylsemduramicin, ≤ 2 %Hydroxysemduramicin, ≤ 2 %Total: ≤ 5 %Chickens for fattening—2025Use prohibited at least five days before slaughter.Simultaneous use of semduramicin and tiamulin may induce a temporary reduction of feed consumption and water intake.10 years from the date to entry into force of Regulation
ANNEX III
40 IU cholecalciferol (vitamin D3) = 0,001 mg cholecalciferol (vitamin D3).Vitamins, provitamins and chemically well defined substances having similar effect
EC NoAdditiveChemical formula, descriptionSpecies or category of animalMaximum ageMaximum content mg/kg of complete feedingstuffOther provisionsEnd of period of authorisation
2. Vitamin D
E 670 a25-hydroxycholecalciferol25-hydroxycholecalciferol(minimum 94 % purity)Chickens for fattening—0,100 mgThe mixture of 25-hydroxylcholecalciferol with vitamin D3 (cholecalciferol) is allowed, provided that the total amount of the mixture does not exceed 0,125 mg/kg complete feedingstuffWithout a time limit
Laying hens—0,080 mgThe mixture of 25-hydroxylcholecalciferol with vitamin D3 (cholecalciferol) is allowed, provided that the total amount of the mixture does not exceed 0,080 mg/kg complete feedingstuffWithout a time limit
Turkeys—0,100 mgThe mixture of 25-hydroxylcholecalciferol with vitamin D3 (cholecalciferol) is allowed, provided that the total amount of the mixture does not exceed 0,125 mg/kg complete feedingstuff.Without a time limit